Process Validation Engineer

Job Summary The Process Validation Engineer supports medical device manufacturing by developing, executing, and maintaining validated manufacturing and test processes. The role ensures compliance with FDA QSR (21 CFR 820), ISO 13485, and cGMP requirements while collaborating cross-functionally to improve process capability, quality, and efficiency across a variety of manufacturing operations. Roles & Responsibilities Develop and execute process validation strategies, including process characterization and creation of IQ, OQ, and PQ protocols and reports. Perform equipment IQ/OQ, process OQ/PQ, test method validation, and Gage R&R studies. Ensure regulatory compliance with FDA QSR, ISO 13485, and internal quality system requirements; participate in audits as needed. Compile, analyze, and interpret validation and SPC data; identify trends and opportunities for continuous improvement. Lead root cause analysis and problem-solving activities for technical and process-related issues using quality and statistical tools. Support and lead change management activities including Change Management System, Nonconformance Reports, CAPA, Engineering Specifications, and Work Instructions. Create, maintain, and improve controlled technical documentation such as prints, procedures, bills of materials (BOM), and routers. Establish, evaluate, and improve manufacturing process methods that meet performance, quality, and CTQ requirements. Conduct feasibility studies to estimate product cost and analyze capital equipment, capacity, and capability requirements. Support a wide variety of manufacturing processes including machining, finishing, forging, casting, cleaning, heat treating, bonding, and molding. Collaborate cross-functionally with Manufacturing, Quality Assurance, Engineering, and other teams to resolve issues, implement strategies, and provide technical support. Develop and execute project plans and schedules; prioritize multiple medium-complexity projects and communicate progress effectively. Communicate project plans and technical direction clearly through written and verbal communication with cross-functional teams. Read and interpret engineering drawings and specifications to support manufacturing and validation activities. " Education & Experience: 46 years of experience supporting medical device manufacturing process validations. Working knowledge of design control, FDA QSR (21 CFR 820), ISO 13485:2003, and cGMP requirements. Proficiency in statistical tools including SPC, PFMEA, CTQ analysis, and general statistics. Experience with Microsoft Office Suite and Microsoft Project. Strong written and verbal communication skills with the ability to work effectively in cross-functional teams.